Randomized,multicenter,double blind comparative trial of reboxetine in the treatment of depression with or without anxiety

Objective To investigate the efficacy and safety of reboxe- fine compared with fluoxetine in patients with depression.Methods This is a muti-center,randomized,double-blind double-dummy, active-controlled study.A total of 212 patients with depression were en- rolled.Subjects were randomized to reboxetine (trial group,n=105) or fluoxetine(control group,n=107) for six weeks.Primary outcome meas- ures changes in scores on 17-items Hamilton rating scale for depression (HAMD17) from baseline to week 6.Secondary measures were the rate respond and recovery according on the scores of HAMD17,total scores in Hamilton rating scale for anxiety (HAMA) and clinical global impression scale (CGI).Results At the endpoint,the scores of HAMD17 de- creased by mean of 15.91 and 15.93 in trial group and control group, respectively.The intention to treat analysis showed non-inferiority of tri- al group over control group.The incidence of adverse events of the two groups were 20.56 % and 28.57 %,respectively.The commom adverse reaction symptoms were as upset,dry mouth,nausea,loss of appetite, dizziness.Conclusion A novel antidepressant agent reboxetine is as effective as fluoxetine and better tolerated in the treatment of depression mixed with anxiety.